(81 days)
JMC612-FL318EPP, JMC612-FL418EPP
Not Found
No
The description details a standard manual wheelchair with no mention of AI or ML features.
No.
The device provides mobility, which is assistive, not therapeutic. Therapeutic devices are typically used for treatment or rehabilitation of an illness or injury.
No
Explanation: The device description states its intended use is to provide mobility to persons restricted to a seated position, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "Steel Wheelchair" with a physical base, wheels, and seat, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide mobility to persons restricted to a seated position." This is a mechanical function for physical support and movement.
- Device Description: The description details a wheelchair with a base, wheels, seat, and features like foldability and flame retardant fabric. These are all components of a mobility aid.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with biological specimens in this way.
- Performance Standards: The performance standards mentioned (ANSI/RESNA WC vol. 1 and ISO 7176) are for wheelchairs, not diagnostic tests.
This device is clearly a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes
IOR
Device Description
The KAIYANG Steel Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it The device uses a standard sling type back and seat, the is foldable easily. upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
KAIYANG Steel Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
JMC612-FL318EPP, JMC612-FL418EPP
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Guangdong Kaiyang Medical Technology Co., Ltd.,
China guồng Trai young
Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 52823 h Tel: +86-757-85502506 Fax:+86-757-85502630 Email:ceirs.jen@msa.hinet.net
OCT 4 2010
510(k) SUMMARY "
Y”
K101999
Submitter's Name: Guangdong Kaiyang Medical Technology Co., Ltd. , Grangaong Tulyang Dali, Nanhai District, Foshan, China, 528231
July 2, 2010
Date summary prepared:
Device Name:
| Proprietary Name: | KAIYAN |
|---|---|
| Common or Usual Name: | Mechanic |
| Classification Name: | Mechanic |
IG Steel Wheelchair cal Wheelchair ical Wheelchair, Class I, 21 CFR 890.3850
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The KAIYANG Steel Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it The device uses a standard sling type back and seat, the is foldable easily. upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
KAIYANG Steel Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
hairean- --------------------------------------------------------------------------------------------------------------------------------------------------------------------
1
Summary for substantial equivalence comparison:
From the above comparison table the intended use between the predicate devices (JMC612-FL318EPP and JMC612-FL418EPP) are the identical structure but made by different materials, steel for JMC612-FL318EPP and aluminum for JMC612-FL418EPP; and new device is made by steel structure. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance-ignitability fabric and also meets the California Technical standard for flame retardant. The C overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Guangdong Kaiyang Medical Technology Co., Ltd. % Dr. Ke-Min Jen Official Correspondent Yanfeng Industrial Area, Dali, Nanhai District Foshan China 528231
4 2010 OCT
Re: K101999
Trade/Device Name: KAIYANG Steel Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 17, 2010 Received: August 25, 2010
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Dr. Ke-Min Jen
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________
Device Name: KAIYANG Steel Wheelchair
Indications for Use:
Indications for USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position._
Over-The-Counter Use AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
S IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K101999 |
|---|---|
| --------------- | --------- |
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